MassDevice

Zoll faces FDA warning letter related to quality, reporting processes

The FDA issued Zoll Medical a warning letter outlining quality system regulation violations and violations of medical device ...
RAPS

FDA final rule reduces radiological devices reporting requirements

The US Food and Drug Administration (FDA) on Thursday issued a final rule that significantly reduces record-keeping requirements for medical devices such as x-rays. The agency said the move will ...
The Lowell Sun on MSN

Chelmsford medical device manufacturer hit with FDA warning letter over violations

CHELMSFORD — Medical device manufacturer Zoll was given a warning letter by the U.S. Food and Drug Administration for what the FDA said were violations of quality systems and medical device reporting ...
Nature

A scoping review of reporting gaps in FDA-approved AI medical devices

Machine learning and artificial intelligence (AI/ML) models in healthcare may exacerbate health biases. Regulatory oversight is critical in evaluating the safety and effectiveness of AI/ML devices in ...
Los Angeles Times

The Life-or-Death Stakes of Medical Device Cybersecurity

Ransomware attacks on the healthcare sector surged by 30 percent in 2025, frequently disrupting operational technology and medical devices. FDA Section 524B mandates that manufacturers provide a ...
Nature

Scaling medical device regulatory science using large language models

Advances in artificial intelligence (AI) and machine learning (ML) have led to a surge in AI/ML-enabled medical devices, posing new challenges for regulators because best practices for developing, ...